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Clorocef

Cefaclor Monohydrate BP

NAME STRENGTH PACK SIZE DOSAGE FORM
Clorocef 15 125 mg/1.25 ml 15 ml Paediatric drops
Clorocef 100 125 mg/ 5 ml 100 ml Powder for suspension
Clorocef 500 500 mg 3X4 Capsule
Clorocef 250 250 mg 3X4 Capsule

Description

Clorocef (Cefaclor) is a second generation broad spectrum semisynthetic cephalosporin antibiotic. It has stability against ß-lactamase. Cefaclor is active against the following organisms in vitro: Aerobes Gram-positive: Staphylococci including coagulase-positive, coagulase-negative and penicillinase-producing strains, Streptococcus pneumoniae, Streptococcus pyogenes group A (ß-hemolytic streptococci) Aerobes Gram-negative: Escherichia coli, Haemophilus influenzae, Klebsiella spp., Proteus mirabilis excluding (ß-lactamase negative ampicillin-resistant strains).

Clorocef 250 Capsule: Each capsule contains Cefaclor 250 mg as Cefaclor Monohydrate BP. Clorocef 500 Capsule: Each capsule contains Cefaclor 500 mg as Cefaclor Monohydrate BP. Clorocef 100 ml Suspension: Each 5 ml reconstituted suspension contains Cefaclor 125 mg as Cefaclor Monohydrate BP. Clorocef 15 ml Paediatric Drops: Each 1.25 ml reconstituted suspension contains Cefaclor 125 mg as Cefaclor Monohydrate BP.

Clorocef is indicated for the treatment of the following infections due to susceptible microorganisms: Respiratory tract infections including pneumonia, bronchitis, exacerbation of chronic bronchitis, pharyngitis, tonsillitis and as part of the management of sinusitis; Otitis media; Skin and soft tissue infections; Urinary tract infections including pyelonephritis and cystitis; It is effective in both acute and chronic urinary tract infections. "

250 mg every eight hours. Children : 20 mg/kg/day in divided doses every 8 hours.

Gastro-intestinal: Diarrhoea, nausea and vomiting have been reported. Hypersensitivity: Allergic reactions such as eruptions, pruritis and urticaria have been observed. These reactions usually subside upon discontinuation of therapy. Serum sickness like reactions have been reported. Haematological: Eosinophilia, thrombocytopenia, transient lymphocytosis and leucopenia may occur rarely. Hepatic: Transient hepatitis and cholestatic jaundice, slight elevation in AST, ALT or alkaline phosphate values have been reported rarely. Renal: Reversible interstitial nephritis has occurred rarely, also slight elevations in blood urea or serum creatinine or abnormal urinalysis. Central Nervous System: Reversible hyperactivity, nervousness, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.

Cefaclor should be administered with caution in the presence of markedly impaired renal function. Modification of usual dosage usually is not necessary in patients with moderate or severe renal impairment. Prolonged use of Cefaclor may result in the overgrowth of non-susceptible organisms. If super infection occurs during therapy, appropriate measures should be taken. If an allergic reaction to Cefaclor occurs, the drug should be discontinued and the patient should be treated with appropriate agents.

Pregnancy: Animal studies have shown no evidence of impaired fertility or teratogenicity. However, caution is recommended in the use of the drug in early pregnancy. Lactation: Small amounts of Cefaclor have been detected in breast milk following administration of single 500 mg doses. As the effect on nursing infants is not known, caution should be exercised when Cefaclor is administered to a nursing mother.

The nephrotoxicity of amino glycoside antibiotics such as gentamicin and tobramicin may be enhanced by any Cephalosporin. Therefore, one should be cautious in concomitant use of these categories of drugs.

Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be anticipated. Treatment: Unless 5 times the normal total daily dose has been ingested, gastrointestinal decontamination will not be necessary. General management may consist of supportive therapy.

Store at room temperature and protect from light. After reconstitution the suspension can be used within 7 days if kept at room temperature and within 14 days if kept in refrigerator (2-8° C). Always keep the bottle tightly closed.

Clorocef is contraindicated in patients hypersensitive to Cephalosporins.

Clorocef 250 Capsule: Each box contains 12 capsules in Alu-Alu blister pack. Clorocef 500 Capsule: Each box contains 12 capsules in Alu-Alu blister pack. Clorocef 100 ml Suspension: Each bottle contains dry powder to reconstitute 100 ml suspension with a spoon. Clorocef 15 ml Paediatric Drops: Each bottle contains dry powder to reconstitute 15 ml drops with a spoon and pediatric dropper.